AbbVie

Specialist I, Scientific Compliance

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Oct 31, 2020
Ref
2008149
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

This position is a part of the compliance organization within Scientific Compliance, Development Sciences. The candidate will ensure compliance in a GMP, GLP and GCP environment with global regulatory, inspecting agency, corporate, ICH, and Office of Ethics and Compliance requirements. The successful candidate must remain current with major compliance trends and application within the pharmaceutical industry. The position requires proactive evaluation of organizational compliance needs and recognition of opportunities to improve business efficiency and productivity.

Key responsibilities include
  • Support Compliance/Business/QA partnership needs and initiatives for continuous improvement to enhance efficiency and compliance
    • Provide input to regulatory and compliance requirements/expectations
    • Identify and appropriately escalate potential compliance risks and/or issues as they arise
    • Use sound and balanced judgment to discern the criticality of issues and act upon them accordingly
    • Identify potential compliance risks and provide potential solutions, including implementation of solutions
    • Manage compliance and process improvement projects to enhance efficiency and compliance
    • Contribute to the development and shaping of quality system policy, process, and procedure
  • Ensure compliance with Quality System elements, including the creation, updating, and other change control activities for quality process and procedures, scientific reports, and scientific publications
    • Change control process implementation for all levels of Quality Documentation
    • Scientific Publications content management and change control in partnership with authors from DevSci functional areas
    • Support internal and external audit activities, including providing pre-audit requests, acting as an SME during an audit and developing and completing audit commitments
    • Electronic system data management, trending, and metrics
  • Work in a highly team-based, cross-functional environment for daily activities, decision-making, and project focus while exhibiting a "one-compliance" voice approach
    • Identify and recommend practical solutions for improved business process efficiency
    • Ability to manage several tasks simultaneously while ensuring all timelines are met
    • Anticipate and respond to urgent and/or unexpected events and changing business needs with minimal impact on productivity
    • Ability to work to identify and solve issues as they arise with minimal supervision
    • Create an open and trusting environment through constructive communication and example

Qualifications
  • Bachelors and 5 years or Masters and 2 years experience, or equivalent experience.
  • Academic background in a scientific discipline is preferred.
  • Working knowledge and experience with GxP regulations, processes, procedures, and documentation requirements for scientific studies and publications
  • Experience working with Scientific Publications and content management preferred
  • Experience with electronic system data management, trending, and metrics
  • Experience working with process, procedure, and document change control processes preferred
  • Experience or interest in Regulatory and Quality Intelligence processes preferred
  • Ability to facilitate discussions and/or meetings while working in a matrixed environment
  • Good interpersonal, presentation, and scientific writing skills

Competencies for Position
  • Builds strong working relationships with team members and cross-functional business partners
  • Embraces the ideas of others, nurtures innovation, and manages innovation to reality
  • Create an open and trusting environment through constructive communication and example
  • Learns fast, grasps the "essence", and can change course quickly where indicated
  • Raises the bar and is never satisfied with the status quo

Level and compensation will be commensurate with experience.

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.